Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023894
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-09-13
Brief Title:
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Flavopiridol NSC 649890 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma
Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 10-24 months
Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma
Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 10-24 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0129M | None | None | None |